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Enhancing productivity
Complete systems for recipe development

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Chemicals, Mechanical & Thermal Processes
Twin screw extruder in pharmaceutical design with gravimetric loss-in-weight feeder, cooling belt and strand pelletizer (Source: Coperion)

With its tailor-made turnkey technological solutions based around the ZSK twin screw extruder, Coperion is responding to the growing demand from the pharmaceutical industry for systems for continuous production processes that offer higher efficiency and uniformity than batch processes. One example of this is a complete pharmaceutical system with a ZSK 18 MEGAlab twin screw extruder with an 18 mm screw diameter that was recently delivered to an international pharmaceutical company. This fully integrated system includes two Coperion K-Tron gravimetric loss-in-weight feeders with superior accuracy in API and liquid feeding, a cooling belt, and a Coperion Pelletizing Technology strand pelletizer. With a maximum throughput rate of 10 kg/h, it is suitable for both wet extrusion and continuous hot-melt extrusion (HME) on a laboratory scale. In the implementation of this system, Coperion leveraged its experience that spans over 30 years in specialty applications for recipe development as well as large production systems for this demanding industry. April 17-19, 2018 Coperion presents its technological solutions at Interphex 2018 (New York, NY, USA, Booth 2261).

Precise, reproducible product quality

One reason for the continually increasing importance of HME processing in the pharmaceutical industry is its intensive mixing effect, as offered by Coperion’s co-rotating ZSK twin screw extruders. As a result, active substances and excipients can be dispersed very finely and homogeneously in pharmaceutical polymers without the use of solvents, which promotes a high degree of bioavailability of the APIs (also BCS classes 2 & 4). In addition, the self-wiping screw profile of these systems eliminates dead spaces. Due to the specific torque of 11.3 Nm/cm3 which allows low ratios of throughput to screw speed, the thermal stress on the APIs and polymers in the ZSK process section is low. Combined with the customized peripheral equipment, these systems make it possible to precisely adhere to the recipe and to create a reproducibly high product quality. In addition, process steps, such as encapsulation or taste masking, can be integrated into the process.

Highly accurate and customized feeding of the ingredients

The integration of the Coperion K-Tron feeders for complete systems ensures optimal dispensing of the formulation ingredients. Coperion K-Tron is known for its highly accurate feeding solutions for pharmaceutical applications. The feeders, which are available as volumetric or gravimetric models, demonstrate a high level of reliability, especially in continuous processes. The wide range of feeder designs makes it possible to feed a very wide range of materials – from the finest powders and pellets to liquids and pastes – to a pharmaceutical process very precisely. Suitable feed systems are even available for ingredients with demanding properties, such as poorly flowing or sticky materials, flooding powders, temperature-sensitive liquids, or substances with a high hazard potential. For complex recipes, several feeders can be grouped around an extruder inlet.

At this year’s Interphex, Coperion K-Tron is pleased to display the newest innovation in pharmaceutical feeder design. The new feeder and scale combination includes modularity for quick feeder exchange, easier access and cleanability, as well as a smaller footprint, ideal for multi feeder clustering around continuous processes.

All Coperion K-Tron feeders have always been specifically designed to meet the stringent requirements of this industry, including compliance with GMP guidelines and the use of FDA-approved construction materials.

Modular system provides maximum flexibility

All ZSK pharmaceutical extruders have a compact design, are easy to operate, and offer optimal accessibility for cleaning and maintenance. For maximum flexibility when feeding liquids and devolatilizing the melt, Coperion uses a modular design for the process section, which includes several barrels in which the co-rotating screws operate. The size-independent Do/Di ratio (outer screw diameter to inner screw diameter) of 1.55 allows reliable scale-up. The systems are designed to comply with GMP guidelines. Customers receive complete documentation for all process parameters (V-Lifecycle) based on a URS (User Requirement Specification).

Precise pelletizing solutions

Coperion Pelletizing Technology offers suitable pelletizers that are specifically designed for pharmaceutical applications. The systems are characterized by their high level of reliability and product quality and have proven themselves many times in practice. Appropriate materials and surfaces are used in order to meet the high requirements of the pharmaceutical industry. Special attention is paid to making the systems easy to access and to clean. Other features, such as pellet length adjustment, can also be realized.

Stefan Gebhardt, General Manager of Business Unit Food & Pharma at Coperion, says: “Like all industries, the pharmaceutical industry is constantly striving to increase process efficiency. Our continuously operating ZSK extrusion systems offer interesting potential, as they increase productivity in comparison to conventional batch processes without compromising on quality, and they require less space. The FDA also supports the trend towards continuous processes because they can accelerate product development and reduce production time. And, as the last link in the chain, patients also benefit from the use of our extruders because the intensive dispersing effect can increase the bioavailability of the incorporated pharmaceuticals, and therefore optimize the effect.”

Chemicals News Processing Technologies

Fusion processes can be triggered by pulsed electric fields

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Pulsed electric fields caused by lightning strikes make themselves felt as voltage spikes and represent a destructive hazard for electronic components. They cause considerable damage. A team from the Helmholtz-Zentrum Dresden-Rossendorf (HZDR) has now discovered that such voltage spikes can have quite useful properties. In the journal Physical Review Research (DOI: 10.1103/PhysRevResearch.3.033153), the scientists report how, for example, nuclear fusion processes can be significantly enhanced by extremely strong and fast pulsed electric fields. Nuclear fusions, such as those that take place in the sun, are made possible by the quantum mechanical tunnel effect.

“One consequence of the tunnel effect is that similarly charged particles can overcome their mutual repulsion, even if their energy is not actually sufficient to do so – at least not according to the laws of classical mechanics. We can observe something like this, for example, in the fusion of two light atomic nuclei: The closer one nucleus approaches the other, the greater the repulsion, which we can imagine figuratively as a mountain piling up in front of the nucleus, the so-called potential barrier. Instead of taking the more energy-consuming path over the top, the laws of quantum mechanics allow the nucleus to penetrate or ‘tunnel’ straight through this mountain in a much more energetically favorable way – and finally to fuse.”

– Prof. Ralf Schützhold, Head of the Department of Theoretical Physics

Although the tunneling effect plays an important role in many areas of physics and was first described nearly one hundred years ago, our understanding of the process is still incomplete today. “Various facets of the influence of electric fields on tunneling processes were already known. For example, electric fields can additionally accelerate particles, helping them to gain more energy. They can also deform the potential barrier and increase the tunneling probability in this way,” says Dr. Christian Kohlfürst, outlining the situation at the beginning of their research.

His colleague Dr. Friedemann Queisser briefly sums up their results: “Our calculations now show for the first time a special feature of pulsed electric fields that change rapidly in time: they can ensure that the particles are pushed out of the potential barrier, figuratively speaking, and thus tunnel more easily.” The calculations of the HZDR team show this quite concretely in various examples, including a fusion reaction of interest for possible energy generation: the fusion of a proton with the isotope boron-11.

Fusion reaction with advantages

It is interesting primarily because of the relatively readily available fuel. Three alpha particles, each with a double positive charge, are produced in the process. What is remarkable about this reaction is that the energy is released in the form of charged particles and not as neutron radiation as in the most well-known fusion reactions at present. This has advantages: For one thing, the problems associated with neutron flux would be significantly reduced, such as the dangers of dealing with ionizing radiation. For another, the energy of charged particles can be converted directly, and thus much more easily, into electricity.

However, the conditions required to use the reaction are even more extreme than those of the deuterium-tritium fusion favored in the current ITER fusion reactor experiment. Igniting the proton-boron reaction is more difficult by comparison, and scientists are still searching for viable ways to do so. Schützhold’s team now points to one possibility: “According to our calculations, a sufficiently fast and strong pulsed electric field can significantly enhance not only deuterium-tritium fusion but also the proton-boron reaction.”

However, generating such fields is very difficult. “In principle, we can think of it as being like a thunderstorm, where the energy stored in huge cloud formations is discharged in the form of a lightning strike in a very short time and in a very confined space. Facilities are being built or planned around the world that are intended to concentrate ever higher energies into ever shorter periods of time and ever smaller spatial areas,” says Schützhold. Unfortunately, the facilities available today are not yet quite capable of generating such fast and powerful “artificial lightning.”

But there is a possible way out: The electric field of an alpha particle flying fast and, above all, close to the proton can act like such a pulsed electric field and strike so strongly that the proton can tunnel through the potential barrier of boron-11 and trigger the fusion reaction. Alpha particles with the necessary pulse energy are actually generated in the proton-boron reaction, but they can also be injected from outside.

 

 

 

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Biotechnology Chemicals News Pharmaceuticals Processing Technologies

Therapeutics and bioinsecticides: production by spider venom

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The venom of a single spider can contain up to 3000 components. The components, mostly peptides, can be used to develop promising active ingredient candidates for the treatment of diseases. Spider venom can also be used in pest control – as a biological pesticide. A team of researchers from the Fraunhofer Institute for Molecular Biology and Applied Ecology IME and the Justus Liebig University Giessen is focusing on native spiders and their venom mix, which have received little attention to date. The research results on the biology of the toxins – especially on the venom of the wasp spider – have been published in scientific journals.

Spiders make many people uncomfortable, and some are even afraid of the eight-legged creatures. At the Fraunhofer Institute for Molecular Biology and Applied Ecology IME in Giessen, however, they are welcome. Here, biochemist Dr. Tim Lüddecke and his team are conducting research on spider toxins.

“Spider toxins are a largely untapped resource, this is partly due to the sheer diversity – some 50,000 species are known. There is a lot of potential in spider venom for medicine, for example in researching disease mechanisms.”

– Dr. Tim Lüddecke, head of the new “Animal Venomics” research group

For example, it is possible to study in the laboratory how individual toxins act on pain receptors of nerve cells. The venom cocktail of the Australian funnel web spider is particularly promising. It is assumed that it can be used to treat neuronal damage after strokes and to make hearts for organ transplants last longer. Other drug candidates are of interest for use as antibiotics or painkillers. “This is a very young field of research. The substances have been discovered and described, but they are not yet in the preclinical stage,” Lüddecke said. Pesticide research is a different story. Spiders stun insects with their venom and then eat them. Because the toxins are very effective against insects, they provide a good basis for biopesticides; they are suitable for crop pest control.

Research to date has focused on the toxins of the very large or potentially dangerous species that live in the tropics. The native, small and harmless spiders have not been in focus. “Most spiders in Central Europe are no more than two centimeters in size, and their venom levels were not sufficient for experiments. But now we have precise analytical methods to study even the small amounts of the previously neglected majority of spiders,” explains Lüddecke. The working group at the Giessen Bioresources branch of the Fraunhofer IME is devoting itself to these species as part of a research project. In the process, they are collaborating with research teams from the Justus Liebig University in Giessen, among others. The work is funded by the LOEWE Center for Translational Biodiversity Genomics (LOEWE-TBG) in Frankfurt am Main.

The scientists are paying particular attention to the wasp spider (Argiope bruennichi), which owes its name to its striking wasp-like coloration. They have succeeded in decoding its venom, identifying numerous novel biomolecules. The research findings were published in the journal Biomolecules.

New biomolecules from wasp spider venom

Spider venoms are highly complex, they can contain up to a maximum of 3000 components. The venom of the wasp spider, on the other hand, contains only about 53 biomolecules. It is heavily dominated by high-molecular-weight components, including so-called CAP proteins and other enzymes. As in other spider venoms, knottins are present – but these make up only a small part of the total mixture.

Knottins represent a group of neurotoxic peptides that are robust to chemical, enzymatic, and thermal degradation due to their nodal structure. One could therefore administer these molecules orally as a component of drugs without digesting them in the gastrointestinal tract. They can therefore exert their effects very well, which is why they offer great potential for medicine. In addition, knottins bind specifically to ion channels. “The more specifically a molecule docks onto its target molecule, attacking only a single type of ion channel, the fewer side effects it triggers,” explains Lüddecke. Moreover, even in small amounts, the knottins affect the activity of the ion channels, i.e., they are effective at low concentrations. As a result, derived drugs can be administered in low doses. The combination of these properties is what makes spider venoms so interesting for science.

The project partners also discovered molecules in the wasp spider’s venom that are similar in structure to neuropeptides, which are responsible for transporting information between nerve cells. “We have found novel families of neuropeptides that we have not previously seen in other spiders. We suspect that the wasp spider uses them to attack the nervous system of insects. It has been known for some time that neuropeptides in the animal kingdom are frequently converted into toxins in the course of evolution,” says the researcher.

Replicating toxins in the lab

Since the toxin yield is low in small spiders, the researchers extract the toxin glands and sequence the mRNA from them. Based on the gene structure, the toxins can be decoded. The venom profile of the wasp spider is now available in its entirety, and the next step is to produce the relevant components. For this, the gene sequence is incorporated into a bacterial cell using biotechnology, which then produces the toxin. “We are building quasi genetically modified bacteria that produce the toxin on a large scale.” Lüddecke and his team have been able to mass produce the main component of the wasp spider toxin, the CAP protein. The first functional studies will start soon.

Venom of male and female spiders differs

In another review paper, the biochemist, in cooperation with colleagues at the Justus Liebig University of Giessen and researchers at the Australian University of the Sunshine Coast, was able to deduce that spider venoms are very dynamic and that many influences shape their composition and functionality. “The dynamics of spider venom have been completely underestimated. The biochemical repertoire is critically influenced by life stage, habitat, and especially sex. Even the venom cocktail of juveniles and adults is not necessarily identical. It is rather the interaction of the many components that makes spider venom so effective than the effect of a single toxin. Through their interactions, the components increase their effectiveness,” the researcher sums up.

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Chemicals Measurement, Instrumentation, Control & Automation Pumps & Compressors

Safe solution to process a wide range of products
Treatment of products with high vacuum

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A very important Germany fine-chemical company has chosen a 3000 liters Bi-Evolution Dryer (model RB 3000) fully equipped with vacuum pump, condensing unit, H/C unit and control-system by Italvacuum. The Bi-Evolution Dryer is Italvacuum’s double cone rotary vacuum dryer that provides high level performances to fulfill the production needs of modern-day firms in the chemical, fine chemical and pharmaceutical industry, amongst many others. It keeps up with today’s increasingly stringent safety regulations, such as Atex, FDA, Asme, cGMP, Ehedg, CE, Ex.

 

 

Italvacuum can provide turnkey installation; the company offers every necessary component for a flawless production process, from vacuum pumps and H/C units together with the control-system. Furthermore the company is also able to serve and support costumers on an international scale in different stages of projects: before the choice thanks to high skilled engineer and the possibility of pilot test in house or off site and during the phase of installation/ after sales thanks to highly specialized staff that can provide scheduled preventive maintenance or prompt technical assistance.

 

For more information about Italvacuum:

www.italvacuum.com

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